Product Usage: The product is intended for use in knee joint replacement arthroplasties.

Code Information

Lots 198810 and 210320

Recalling Firm/Manufacturer

Zimmer Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989

For Additional Information Contact

411 Technical Services574-371-3071

Manufacturer Reasonfor Recall

Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.

On May 24, 2018, Zimmer Biomet issued an Urgent Medical Device Recall letter to its affected consignees via email and FedEx. The letter informed customers of the product commingling issue. Customers were instructed to take the following actions:
Distributors:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com.
a. Review the list of hospitals included with the email notification sent to your facility, which includes a list of hospitals that have already been notified of this recall.
b. Identify whether there are any additional hospitals that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format.
c. If there are no additional accounts to notify, please indicate that there are no additional accounts, or indicate None or NA on the form.
Risk Managers:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.Po

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.